Martin Avenue Pharmacy Recalls Compounded Sterile Diazepam Preparations
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Diazepam, due to quality control issues affecting sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility assurance for injectable products, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action includes Diazepam 5 mg/mL injectable packaged in amber glass vials. The recall is being initiated in connection with a recent FDA inspection.
The recall is due to observations associated with certain quality control procedures that present a risk to sterility assurance. The source text indicates a lack of assurance of sterility for these products.
The recall is described as nationwide. Consumers and healthcare providers should stop using these products and contact Martin Avenue Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 08192014@50
- Exp 11/17/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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